Kornimate/medical-research-clean huggingface dataset:
hyaluronic acid-enriched transfer medium in single blastocyst transfer

Conditions: Infertility

Summary: the purpose of this study is to compare the live birth rates of high concentration of hyaluronic acid (0.5 mg/ml) transfer medium (embryoglue®) to those containing low hyaluronic acid concentrations (0.125 mg/ml) (g2 medium) in women undergoing single fresh and frozen blastocyst transfer.

the single blastocyst-stage embryo transfer cycles will be randomised in a 1:1 allocation, with block sizes of 2 and 4 on the day of embryo transfer (et). this randomisation process will be centrally managed via a web-based electronic data capture system and will be stratified according to the treatment center. the allocation sequence and the designated treatment will be completely concealed from the participating couples, clinicians - including those conducting the transfer procedures - and outcome assessors. given the intrinsic viscous nature of embryoglue, embryologists, who who are responsible for the procedures in the laboratory will not be subjected to blinding. only at the end of the study, when data collection is completed, the allocation sequence will be revealed to the primary investigators.

Eligibility criteria:
inclusion criteria: 1. all cycles with single blastocyst transfer will be considered eligible 2. both fresh and cryopreserved embryo transfer cycles utilizing autologous oocytes 3. no age restriction will be applied 4. informed consent was signed exclusion criteria: 1. uterine anatomic anomalies 2. women with untreated hydrosalpines 3. once couples have been enrolled in the trial, subsequent cycles will not be incorporated.

Keywords: hyaluronate-enriched medium live birth single blastocyst transfer
prediction of clinical course in covid19 patients

Conditions: COVID 19

Summary: in the context of the covid19 pandemic and containment, chest ct is currently frequently performed on admission, looking for suggestive signs and basic abnormalities of covid19 compatible viral pneumonitis pending confirmation of identification of viral rna by reverse-transcription polymerase chain reaction(pcr), with a reported sensitivity of 56-88% in the first few days, slightly higher than pcr (60%) (1). nevertheless, currently established radiological abnormalities are not specific for covid19 and the specificity of the chest ct is \~25% when pcr is used as a reference (1). deconfinement and its consequences will complicate the triage of covid patients and the role of the scanner, with the expected impact of a decrease in the prevalence of infection in the emergency department and an increase in the number of "all-round" patients, including patients with non-covid viral infiltrates or pneumopathies. in addition, there are currently no imaging criteria to complement the clinical and biological data that can predict the progression of lung disease from the initial data.

in image processing, computational medical imaging has demonstrated its ability to predict a therapeutic response or a particular evolution after extracting relevant anatomical, functional or even non-visually perceptible information from the volume of images, making it possible to construct a powerful radiomic signature or to use robust anatomical/functional measurements to provide estimates of ventilation or vascular state. by combining these data extracted from the scanner with the standard clinical-biological data produced at admission during triage, our ambition is to build a predictive model using unsupervised classification approaches capable of helping predict clinical evolution with the aim of optimizing the management of the resource.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * clinical suspicion of covid-19 confirmed by rt-pcr * ct scan at er admission * rt-pcr sampling exclusion criteria: * ct scan failure or loss of ct data * rt-pcr initial results unavailable

Keywords: covid 19 chest ct scan
adherence risk indicator validation study

Conditions: Obstructive Sleep Apnea

Summary: while continuous positive airway pressure (cpap) is the gold standard treatment of obstructive sleep apnea (osa), this therapy is often discontinued or not used optimally. the adherence risk indicator (ari) is a statistical model based on answers from a questionnaire. the data collected from this trail allows for closer monitoring of at-risk patients. for the study, participants are provided with a questionnaire prior to starting cpap therapy for osa. participants will be provided with a gsm (global system for mobile communication) modem to allow transmission of their cpap data. participants data will be retrieved at 7, 14, 21, 30 and 90 days to test the accuracy of the ari prediction. at the conclusion of the study the gsm unit is returned, and participants continue with cpap therapy as instructed by their healthcare provider.


Eligibility criteria:
inclusion criteria: * ≥ 18years of age * diagnosed with osa (ahi \>5 events/hour) and eligible for cpap (fixed or auto) treatment under local requirements * naïve to cpap therapy, i.e. have not been prescribed cpap in the past 5 years exclusion criteria: * contraindicated for cpap therapy * medically unstable condition/diagnosis that is not yet under control * co-existing sleep disorder (however clinically diagnosed insomnia can be included in the study) * plma (periodic limb movement activity) index greater than 15/hr * home titration of longer than 5 days
families coping together with alzheimer's disease

Conditions: Family Research; Dementia

Summary: two remote phone/zoom calls are required to assess experiences as a family coping with dementia.

using a combination of paper or online surveys in addition to interactive visits with blood pressure monitoring, participants are observed interacting with each other. blood pressure devices are mailed to their homes and only worn for six minute intervals. the first visit generally lasts one hour and the second visit 90 minutes.

Eligibility criteria:
inclusion criteria: * parent must be 55 plus with symptoms or a diagnosis of dementia * adult child must be over 18 and involved in some way with assisting parent. exclusion criteria: -
bioequivalence study of ezetimibe tablets under fed conditions in healthy subjects

Conditions: Pharmacokinetics; Safety

Summary: the fed bioequivalence test adopts the experimental design of single center, single oral administration, random, open, two sequence, two cycle crossover and self-control.

to investigate the in vivo pharmacokinetic characteristics of ezetimibe tablets (specification 10mg) in chinese healthy subjects after a single oral administration under fed conditions, and to evaluate the bioequivalence of ezetimibe tablets produced by changzhou pharmaceutical factory co., ltd. and the licensee msd pharma (singapore) pte. ltd. to study the safety of single oral ezetimibe tablets (specification 10mg) in chinese healthy subjects.

Eligibility criteria:
inclusion criteria: * • healthy male or female aged 18 and above. * the body mass index is in the range of 18.6-28.5 kg/m2 (including the critical value). the weight of male is not less than 50.0 kg, and that of female is not less than 45.0 kg. * the following examination show that the indicators are normal or abnormal without clinical significance. the examination including: vital signs, physical examination, blood routine, blood biochemistry, urinalysis, pregnancy test for female, serological tests for hepatitis b virus, hepatitis c virus, human immunodeficiency virus (hiv), and syphilis virus, 12 lead ecg, breath test for alcohol, drug abuse test. * the subjects have no family planning within 3 months and could select contraceptive method. * before the study, all subjects have been informed of the study's purpose, protocal, benefits, and risks, and signed the informed consent voluntarily. exclusion criteria: * • being allergy to the study medications, smoking, alcohol abuse. * participation in another clinical trial within 3 months.

Keywords: ezetimibe
diagnostic utility of otosight middle ear scope

Conditions: Ear Infection; Middle Ear Infection; Otitis Media

Summary: evaluate clinic workflow impact of otosight use for patients seen in the pediatric otolaryngology clinic.

the purpose of this study is to compare the successful exam completion rate, the detection of middle ear fluid (versus no fluid), and the categorization of middle ear fluid (purulent vs. serous vs mucoid,) of routine otoscopy examination versus otosight examination versus tympanogram.

Eligibility criteria:
inclusion criteria: * patients aged 6 months to 12 years old who are seen in the outpatient otolaryngology clinic at texas children's hospital main and west campuses. exclusion criteria: * patients who have a history of ear tube placement

Keywords: otoscope tympanogram
a long-term extension study of tak-385 in the treatment of endometriosis

Conditions: Endometriosis

Summary: the purpose of this study is to compare the long term safety and efficacy of tak-385, once daily (qd) following continued administration in participants who completed a phase ii dose-finding study.

this study is a long-term extension study for evaluation of the safety and efficacy of tak-385 following administration for 24 weeks (calculated from visit 3 in the tak-385/cct-101 study) in participants from the phase ii dose-finding study (tak-385/cct-101 study).

Eligibility criteria:
inclusion criteria: 1. participants who have completed tak-385/cct-101 study exclusion criteria: 1. participants who had an adverse event in tak-385/cct-101 study which makes continued administration of the study drug difficult 2. participants who became unable to comply with the protocol due to onset of a new disease, symptom, finding, or aggravation of clinical laboratory findings 3. participants in whom investigator deems that the study drug shows no efficacy based on the level of pain, menstruation status, and the status of analgesic drug intake in tak-385/cct-101 study, or that study continuation represents an unacceptable risk 4. participants in whom investigator deems that study continuation is difficult due to the occurrence of low estrogen symptoms in tak-385/cct-101 study which were attributed to the pharmacological effects of the study drug taking into account the level and frequency of the adverse events etc. as well as the risk-benefit of participants.

Keywords: drug therapy
incidence of expression of tumor antigens in cancer tissue from patients with pathologically demonstrated bladder cancer

Conditions: Neoplasms, Urinary Bladder

Summary: this study aims to analyze the incidence of expression of mage-a3, mage-c2, ny-eso-1, lage-1, wt1 and prame tumor antigens in cancer tissue from patients with pathologically demonstrated bladder cancer.

there will be no procedure(s) or treatment(s) carried out on patients. all data and samples will be taken from those already stored at the investigation sites. clinical data collected will include patient demographics (age, gender), tumor, node, metastasis (staging system) \[tnm stage\], and histopathologic description only. strict anonymity of patient data will be maintained. this retrospective study is based upon the analysis of archived formalin-fixed paraffin-embedded tissue samples and patient-related data already available at the investigational site.

Eligibility criteria:
inclusion criteria: for inclusion of a tissue sample, all of the following criteria must be met: * the patient had pathologically proven bladder cancer (any stage). * all the data required are available from patient's records. there are no restrictions regarding operative technique (cystectomy or cystoscopy). - many patients may no longer be alive, or no longer be in contact with the investigation sites. thus, patients will not be required to give their informed consent before inclusion in the study. exclusion criteria: * not applicable.

Keywords: patients tumor antigens bladder cancer
irradiation modulates the pharmacokinetics of anticancer drugs

Conditions: Rectal Cancer; Cervical Cancer

Summary: radiation therapy (rt) is used as an effective local treatment modality to inhibit cell proliferation, induce cell death and suppress tumor growth. to improve the treatment outcome, in terms of both locoregional control and survival, the concurrent use of chemotherapy during radiation therapy (ccrt) is now the standard treatment for various malignancies, especially locally advanced cancers. among the drugs used to enhance rt effect, 5-fluorouracil (5-fu) is one of the most commonly used chemotherapeutic agents of ccrt. in the past, rt was solely used as a local treatment and its effect was estimated by local effect model. however, growing evidence shows that irradiation has direct dna damage-dependent effects as well as sending signals to neighboring cells. recently, we reported that abdominal irradiation could significantly modulate the systemic pharmacokinetics of 5-fu at 0.5 gy, off-target area in clinical practice, and at 2 gy, the daily treatment dose for target treatment in an experimental rat model. additionally, the results from a clinical investigation showed that colorectal cancer patients with lower auc of 5-fu during adjuvant chemotherapy had lower disease-free survival. taken together, these lines of evidence support the importance and necessity to search for the mediators responsible for the unexpected effect of local rt on systemic pharmacokinetics of chemotherapeutic agents, such as 5-fu. in the present study, the investigators investigated whether the phenomena and mechanism of rt-pk is a fact for different anticancer drugs in human.


Eligibility criteria:
inclusion criteria: * world health organization (who) performance status of 0 or 1 * age 18-80 years * locally advanced rectal cancer * locally advanced cervical cancer exclusion criteria: * cancer history * abnormal liver and renal disease * immune disease * hematological disease

Keywords: radiation therapy 5-fluorouracil cisplatin pharmacokinetics matrix metalloproteinase
phase iii study of vincristine sulfate liposome for injection in adults with naïve acute lymphoblastic leukemia

Conditions: Adult Acute Lymphoblastic Leukemia

Summary: the purpose of this study is to determine whether vincristine sulfate liposome could reduce less peripheral neuropathy than vincristine sulfate,and be as effective as vincristine sulfate in adults with naïve acute lymphoblastic leukemia.


Eligibility criteria:
inclusion criteria: * de novo untreated all patients diagnosed by the bone marrow morphology, immunophenotype. * 65 ≥ age (years) ≥ 18 , male or female, * ecog performance status of 0, 1, or 2. * patients must fulfill the following laboratory values 1. total bilirubin ≤2 uln (corrected for same age) 2. ast and alt ≤3 uln ( corrected for same ages) 3. serum creatinine ≤2 uln (corrected for same age) * didn't receive any of the following treatments within 4 weeks before inclusion: chemotherapy, radiotherapy, replacement therapy, operation, long term of glucocorticoid therapy（\>5 days）. * no neurological disorders, no nerve or muscle injury (motor and sensory nerve). * patient must sign the informed consent and obey the protocol. exclusion criteria: * atopy or allergic to multiple medicines or excipients. * with serious complications that affect compliance. * serious organ dysfunctions or central nervous system disorders. * mixed phenotype acute leukemia, (t-b). * burkitt lymphoma/leukemia. * suspected or confirmed central nervous system leukemia. * diabetes. * received antifungal treatment with triazole agents within 1 month before inclusion. * reliance of antipyretic and analgesic medicines or psychotropic medicines. * undergoing or has undergone other clinical trials in 4 weeks before inclusion. * pregnant women, women of breast feeding or childbearing potential without contraception. * psychological disorders that affect signing consent. * the investigators believe that patients who are not suitable for inclusion.

Keywords: adult acute lymphoblastic leukemia vincristine sulfate liposome vincristine sulfate
oxidative stress in microvascular dysfunction following gestational diabetes

Conditions: Gestational Diabetes; Vascular Endothelial Function

Summary: the purpose of this investigation is to examine the role of oxidative stress in aberrant microvascular function in otherwise healthy women with a history of gdm.

women with a history of gestational diabetes mellitus (gdm) are at a 2-fold greater risk for the development of overt cardiovascular disease (cvd) following the effected pregnancy. while subsequent development of type ii diabetes elevates this risk, prior gdm is an independent risk factor for cvd morbidity, particularly within the first decade postpartum. gdm is associated with impaired endothelial function during pregnancy and decrements in macro- and microvascular function persist postpartum, despite the remission of insulin resistance following delivery. collectively, while the association between gdm and elevated lifetime cvd risk is clear, and available evidence demonstrates a link between gdm and vascular dysfunction in the decade following pregnancy, the mechanisms mediating this persistent dysfunction remain unexamined. the purpose of this investigation is to examine the role of oxidative stress in mediating vascular dysfunction in women who have had gestational diabetes. in this study, the investigators use the blood vessels in the skin as a representative vascular bed for examining mechanisms of microvascular dysfunction in humans. using a minimally invasive technique (intradermal microdialysis for the local delivery of pharmaceutical agents) they examine the blood vessels in a dime-sized area of the skin in women who have had gdm. as a compliment to these measures, the investigators also collect endothelial cells from an antecubital vein and measure markers of oxidative stress and insulin-mediated enos phosphorylation in these cells.

Eligibility criteria:
inclusion criteria: * female sex * 18 -50 years old * pregnancy history within 5 years of the study visit * had gestational diabetes diagnosed by their obstetrician and confirmed according to the american college of obstetricians and gynecologists criteria for gestational diabetes * or without a history of gestational diabetes exclusion criteria: * skin diseases * current tobacco/e-cigarette use * diagnosed or suspected hepatic or metabolic disease including diabetes * statin or other cholesterol-lowering medication * current antihypertensive medication * history of preeclampsia or gestational hypertension * current pregnancy * body mass index \<18.5 kg/m2 * allergy to materials used during the experiment.(e.g. latex), known allergies to study drugs.

Keywords: gestational diabetes postpartum vascular
aging well, sleeping efficiently: protecting health in later life

Conditions: Sleep; Health Promotion

Summary: the purpose of this study is to see whether protecting sleep quality in later life is important in continued healthy aging. the value of education in healthy sleep practices along with reducing time in bed each night by going to bed 30 minutes later, and of healthy dietary practices will be tested for their effects on sleep quality, health, and well being.

the goal of this project is to test the efficacy of restricting time in bed and education in healthy sleep practices for maintaining or even enhancing sleep consolidation and depth in subjects aged 75+ who are at risk for decay in sleep quality and daytime well being; to determine the associated benefits for health; and to examine the persistence of such effects for 12 months beyond the end of the 18-month intervention. this project focuses not on pathology but on prevention of sleep decay and preservation of sleep in individuals who have already evidenced successful aging.

Eligibility criteria:
inclusion criteria: * age 75 or older * without sleep disorders * without psychiatric disorders * folstein mmse of 24 or greater exclusion criteria: * apnea-hypopnea index greater than 30 * mean sleep latency less than 6 * psychotropic medications present

Keywords: sleep sleep hygiene modest sleep deprivation healthy aging and sleep health promotion
inflammatory arthritis and tango

Conditions: Rheumatoid Arthritis (RA); Spondyloarthritis (SA)

Summary: the hypothesis is that pleasure brought by argentine tango practice would increase total physical activity of patients with chronic inflammatory arthritis.

selection and inclusion of patients will be done by principal investigator of rheumatology department. after verification of inclusion and non-inclusion criteria by principal investigator and signature of consent, patients will be randomized by 1: 1 randomization (centralized randomization by statistician into 2 groups at m0). they will participate in sessions in a deferred manner due to two per week for each group: * interventional "a" group: 48 sessions (on average 2/week) performed from m0 to m6 in 30 patients. * control "b" group: 24 sessions (on average 2/week) performed from m3 to m6 in 30 patients. patients of "b" group will be not performing sessions with "a" group patients. sessions lasting about 60 minutes will be proposed from monday to friday in a room planned from this activity within the chu. they will be adapted and personalized according to each one. evaluations will be carried out for group 1 (interventional) before the first session of tango at m0, before the session at m3 and at the end of the protocol at m6. the same evaluations will be carried out for group b (control) at m0, before first session of tango at m3 and at the end of the protocol. assessment of pain and stress will be done before and after each session. final assessment will be done at 6 months after randomization. fitness assessment and tango sessions will be conducted by an argentine tango teacher

Eligibility criteria:
inclusion criteria: * patient age \> 18 years old with ra (acr/eular criteria) in remission (cdai ≤2.8) or with low disease activity (cdai ≤10), or with sa (asas criteria) with activity deemed stable by rheumatologist. * patient able to walk without help * patient able to complete a questionnaire * patient giving informed consent. * patient covered by social security exclusion criteria: * patient with disorder of higher mental function or psychiatric disorders. * patient practicing argentine tango. * patient with an absolute contraindication to physical activity. * protected populations: pregnant women, breastfeeding women, tutorship, trusteeship, deprived of liberty, safeguard of justice.

Keywords: chronic inflammatory arthritis argentine tango physical activity